Oxybutynin Chloride
- Product NDC
- 10135-611
- 11-digit product format
- 101350611
- Labeler code
- 10135
- Product ID
- 10135-611_da063b55-10e9-4231-9f23-22216f257455
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxybutynin Chloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA204010
- Marketing category
- ANDA
- Marketing start
- 2016-02-01
- Marketing end
- 0000-00-00
- Substance
- OXYBUTYNIN CHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 10135-611 | I | Inactivated by FDA | 2026-08-07 | ||
| excluded package | package | 10135-611 | 10135-611-01 | I | Inactivated by FDA | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 10135-611-01 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 10135-611-01 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204010-001 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | |
| A204010-002 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | |
| A204010-003 | OXYBUTYNIN CHLORIDE | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204010-001 | AB |
| A204010-002 | AB |
| A204010-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-002 | OXYBUTYNIN CHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-003 | OXYBUTYNIN CHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204010-001 | OXYBUTYNIN CHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-11-23 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A204010-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204010-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204010-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204010-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204010-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204010-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204010-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204010-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204010-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204010-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204010-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204010-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204010-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204010-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204010-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204010-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 8 | 20230316 |
| 4daffbf2-44c8-ca46-d284-5db69e1e6ef4 | Product name | 8 | 20210525 |
| 982338c6-c45c-b6b4-1452-14b01fbdf98d | Product name | 2 | 20180801 |
| 054197ba-7ed3-0ddb-321e-dbb51c0fe9b6 | Product name | 2 | 20171212 |
| 3544f362-07fc-93b1-457b-1fba00be087a | Product name | 2 | 20171212 |
| 8b00ae7e-01f2-f83c-632e-edfc23808364 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10135-611-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5366-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use oxybutynin chloride extended-release tablets safely and effectively. See full prescribing information for oxybutynin chloride extended-release tablets. OXYBUTYNIN chloride extended-release tablets, USP for oral use. Initial U.S. Approval: 1975 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-611-01 | Oxybutynin Chloride | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-611-01 | EA - Each | 10135-611 | c3808c66-f29a-4bad-aef1-f7a893496cae | 1 | 2016-05-16 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Major Pharmaceuticals | 7688cce8-797d-454c-95fb-52689741582e | 2025-07-15 | Warnings, Adverse reactions | 204010 ANDA204010 |
| Oxybutynin Chloride | OXYBUTYNIN CHLORIDE | Amneal Pharmaceuticals LLC | 53924eba-1919-4203-9a1e-d57dfdd3b963 | 2023-02-02 | Warnings, Adverse reactions | 204010 ANDA204010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 863619 | oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet | PSN | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863628 | oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet | PSN | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863636 | oxyBUTYnin chloride 5 MG 24HR Extended Release Oral Tablet | PSN | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863619 | 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet | SCD | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863628 | 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet | SCD | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863636 | 24 HR oxybutynin chloride 5 MG Extended Release Oral Tablet | SCD | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863619 | oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet | SY | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863628 | oxybutynin chloride 15 MG 24 HR Extended Release Oral Tablet | SY | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
| 863636 | oxybutynin chloride 5 MG 24 HR Extended Release Oral Tablet | SY | 301a7fca-c556-4b53-899f-bc7e2a74ded8 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10135-611-01 | 10135061101 | 100 in 1 BOTTLE, PLASTIC | Historical |